NCT02750527

Brief Summary

This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,049

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

4.3 years

First QC Date

April 21, 2016

Last Update Submit

June 15, 2021

Conditions

Type 1 DiabetesFamilial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • number of familial hypercholesterolemia or pre-type-1-diabetes

    identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes

    18 month

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

According to the Federal Statistical Office (31.12.2014) 320.000 children in the age of 2 to 6 years are living in lower Saxony, Germany. Based on the Fr1da experience a participation rate of 25-35 % is expected. The current estimated prevalence of FH und T1D of 1:300 leads to the expected number of 450 newly identified cases of FH and T1D in each case in the period of 18 months. Additional subjects with FH would be identified by cascade screening.

You may qualify if:

  • Children living in Lower Saxony (primary residence)
  • Age between 2 and 6 years (both included)
  • Written consent by at least one parent / legal representative
  • Willingness to deliver 200 µl of capillary blood
  • Willingness to complete a questionnaire
  • Willingness to participate to the follow-up visits

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Olga Kordonouri, MD

    Kinder- und Jugendkrankenhaus AUF DER BULT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 25, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share